Fastening Device
A fastening device is provided to be associated with a first object, for the attachment of the object to a second object. The device comprises at least one fastening element having a base portion and at least one securing portion. The fastening element is originally produced with its securing portion having a first orientation relative to the base portion and with a possibility to bring the securing portion into a second orientation relative to the base portion, to allow the at least one securing portion to penetrate the second object being exposed thereto while staying in the second orientation, and being adapted to change the second orientation into the first orientation to provide the attachment.
This present invention relates to fastening devices and methods for the attachments of objects to each other, in particular to medical fastening devices and methods, especially those used for anastomosis.
BACKGROUND OF THE INVENTIONFastening devices of the kind to which the present invention refers generally comprise elements which are most often adapted to penetrate object or objects to be attached by them and their orientation may be changed during the penetration. Examples of different connectors of this kind are presented below.
U.S. Pat. No. 5,597,378 discloses medical devices incorporating SIM alloy elements. Medical devices which are currently proposed to use elements made form shape memory alloys may be improved by the use of stress-induced martensite alloy elements instead. The use of stress-induced martensite decreases the temperature sensitivity of the devices, thereby making them easier to install and/or remove.
U.S. Pat. No. 5,207,695 discloses an aortic graft, implantation device, and method for repairing aortic aneurysm. An aortic graft and system and method for implanting the aortic graft are provided. The aortic graft comprises a substantially cylindrical graft material with attachment means which comprise a plurality of post and hook assemblies which are implanted with a double catheter system to penetrate the aorta wall above and below the aneurysm to provide firm attachment of the aortic graft and, thereby, exclude the aneurysm from the circulatory system.
U.S. Pat. No. 7,081,132 discloses a flexible barb for anchoring a prosthesis. A barbed medical prosthesis is disclosed in which the barb includes a basal portion comprising a point of union with the substrate of origin (such as a strut), an anchoring portion adapted to embed into tissue, and a stress-dispersing portion located between the basal and anchoring portions. In one embodiment the stress-dispersing portion comprises a helical coil having a free winding that is unattached to the strut from which the barb extends. In another embodiment, the stress-dispersing portion comprises a series of bends or curves formed in the barb proximate to the point of union with the strut. The barb can be mechanically attached and/or soldered to the prosthesis, or integrally formed therefrom. A second barb portion and stress-dispersing portion, may also extend from the basal portion.
US 20050256531 discloses an apparatus and methods implant a fastener in a targeted body region, e.g., a hollow body cavity or an intraluminal space. The apparatus and methods deploy in the targeted body region a fastener attachment assembly that carries an actuated member. The actuated member is selectively operable to generate an implantation force to implant a fastener into tissue within the targeted body region. The fastener can be implanted, e.g., to secure a prosthesis, e.g., an endovascular graft. The systems and apparatus apply a resolution force at or near the actuated member, thereby making possible a stable and dependable catheter-based fastening platform.
US 20060030921 discloses a method and apparatus for a securement device useful for the treatment of aneurysms includes a hub and, in one aspect, a plurality of arms or spikes in a star pattern extendable therefrom and into engagement with a blood vessel wall. The securement device may be deployed to anchor a secondary device, such as an exclusion device for example a stent graft, in position in a flow lumen and thereby prevent the migration of the exclusion device in the flow lumen. The arms may be positioned to penetrate through the exclusion device and thence into the flow lumen wall to provide such securement.
U.S. Pat. No. 6,358,258 discloses a device and method for performing end-to-side anastomosis. Devices, methods, and kits are provided for suturing an end of a first body duct to a hole in the side of a second body duct. The present devices and methods are used to simplify the suturing procedure and thus reduce operating time. In one embodiment, the present device includes a structure for holding the end of the first body duct and positioning the end adjacent to the hole in the side of the second body duct. The structure of the device is typically a shaft having a surface adapted to receive the first body duct. A plurality of needles are arranged on the structure to be advanced along a plurality of paths. Each needle path first passes radially into and forwardly out of the end of the first body duct and into the hole of the second body duct. The path then everts so that the needles and associated sutures will pass outwardly through tissue peripheral to the hole when the end of the first body duct is on the structure adjacent to the hole in the second body duct. The needles preferably travel along such paths when they are advanced forward. In one embodiment, the device uses a J-shaped tube for guiding one of the needles along the desired path. In another embodiment, shape-memory needles having an arcuate profile are used to create the desired path.
U.S. Pat. No. 7,048,747 discloses a device and method for performing end-to-side anastomosis. Devices, methods, and kits are provided for suturing an end of a first body duct to a hole in the side of a second body duct. The present devices and methods are used to simplify the suturing procedure and thus reduce operating time. In one embodiment, the present device includes a structure for holding the end of the first body duct and positioning the end adjacent to the hole in the side of the second body duct. The structure of the device is typically a shaft having a surface adapted to receive the first body duct. A plurality of needles are arranged on the structure to be advanced along a plurality of paths. Each needle path first passes radially into and forwardly out of the end of the first body duct and into the hole of the second body duct. The path then everts so that the needles and associated sutures will pass outwardly through tissue peripheral to the hole when the end of the first body duct is on the structure adjacent to the hole in the second body duct. The needles preferably travel along such paths when they are advanced forward. In one embodiment, the device uses a J-shaped tube for guiding one of the needles along the desired path. In another embodiment, shape-memory needles having an arcuate profile are used to create the desired path.
U.S. Pat. No. 6,645,227 discloses a suture anchor including a placement portion frangably connected to an attachment portion. The attachment portion includes an outwardly projecting barb. During insertion of the suture anchor within a bore hole formed on a bone, the barb scores at least a portion of the bone bounding the bore hole. Once the suture anchor is disposed within the bore hole, a withdrawal force is applied to the suture anchor such that the attachment portion thereof rotates within the bore hole and disconnects from the placement portion. In an alternative embodiment, the suture anchor can be formed without the outwardly projecting barb.
U.S. Pat. No. 6,363,938 discloses an apparatus and methods provided for forming a channel in an organ or vessel to enhance perfusion therein. The apparatus may include a bioactive agent to stimulate tissue growth and vascularization in tissue adjacent to the channel. The apparatus includes a stent, suitable for percutaneous or intraoperative placement, that includes a tubular member having a plurality of tines, barbs, ribs or other structure to secure the stent at a desired position within tissue.
US 20050125020 discloses methods and apparatus for anchoring within the gastrointestinal tract. The present invention relates to an anchor configured for minimally-invasive implantation and sized to remain securely positioned within at least a portion of the gastrointestinal tract of an animal. The anchor includes a radial spring formed from an elongated resilient member shaped into an annular wave pattern about a central axis. The anchor defines a central lumen and provides an outward radial force, while allowing for substantial flexure about its perimeter. The anchor is generally removable, but can include fasteners, such as barbs, to further secure it to the surrounding anatomy. In some embodiments, the anchor includes a connector coupling a fixed portion to a removable portion. Further, the anchor can be used to secure a medical device within the body, such as a flexible sleeve within the intestine.
US 20040068217 discloses methods and apparatus for making an anastomotic connection between a first aperture in a side wall of a graft conduit and a second aperture in a side wall of a body tissue conduit using a hollow self-expanding exterior connector. The tissue about the first aperture is introduced into the hollow connector and is retained by first members of a distal portion of the connector. A delivery tool then collapses the distal perimeter defined by the first members by deforming the connector and delivers the first members into the lumen of the body tissue conduit via the second aperture. Upon inserting the first members into the body tissue conduit, the tool is disemployed and the connector reforms such that the first members and a more proximal portion of the connector external to the body tissue conduit press together the walls of the two conduits around the apertures.
WO 2005/004727 discloses a surgical fastening device for pinning a surgical filament to a body tissue. The device includes a grasping handle and a slender shaft extending from the grasping handle. A compartment contains one or more surgical fasteners. An ejecting mechanism is used to eject a surgical fastener from a compartment containing one or more surgical fasteners. The device also includes a filament dispensing system that dispenses surgical filament along the shaft so that a fastener grasps the filament when being ejected from the shaft. The invention also provides surgical fasteners and surgical filaments for use in the device.
WO 96/02211 discloses an intraluminal stent. An improved stent provides mechanical anchoring of the stent to a blood or other body vessel. The stent has, in a preferred embodiment, barbs (18) which remain within the surface of the stent when the stent is in its unexpanded condition, but which extend from the surface of the stent when the stent is expanded. These barbs (18) are adapted to engage, for example, a graft and/or the inner layers of a blood vessel to mechanically attach the stent to the vessel. Because friction is not solely relied upon to hold the stent in place, the stent may exert less force on the blood vessel which, in turn, means that a thinner stent requiring less force for expansion may be used. In addition, there may be less radial force permanently exerted in an artery after stent deployment which may be less injurious to the vessel.
WO 90/015582 discloses an aortic graft and system and method for implanting the aortic graft. The aortic graft comprises a substantially cylindrical graft material with attachment means which comprise a plurality of post and hook assemblies which are implanted with a double catheter system to penetrate the aorta wall above and below the aneurysm to provide firm attachment of the aortic graft and, thereby, exclude the aneurysm from the circulatory system.
WO 2003/099167 discloses an endoluminal device having barb assembly. An endoluminal device for implantation in a body lumen reduces movement or migration of the device after implantation by the use of barbs or barb assemblies. A first embodiment uses at least one barb assembly having first portions attached to an implant, a bend, and second portion disposed opposite the first portion from the bend and having a bearing surfaced. The second portion is adapted to protrude radially inward when the implant is in the radially compressed configuration and radially outward when the implant is in its radially expanded configuration. A second embodiment uses a barb having a curved segment which is curved proximally and radially inwardly. A third embodiment utilizes at least one barb assembly having a wire with a length greater than the cell height of the implant across which it extends and a substantially uniform cross-sectional area.
SUMMARY OF THE INVENTIONThe present invention relates to devices and methods of fastening objects to each other based on the penetration of at least one of the objects, which objects may thus each be made of fabric or the like natural or artificial material, which may but does not necessarily have to, be in the form of a layer of any shape including curvilinear or planar shapes, which further may be a tissue, including biological tissue such as, for example a wall of a blood vessel.
The term “fastening” in the context of this application, designates, in addition to the common meaning of this term, also connecting or fixating two or more objects one to each other, either touching each other or not, or to create a structure out of few objects in the form of layers connected together. If used in medical applications, such fastening can refer, for example, to anstomosis of blood vessels in various configurations (e.g., side to side, end to end, end to side), or to anchoring of objects such as fastening grafts, vascular bypasses, connecting artificial (aortic) valves to their place, anchoring a sensor within a cavity of human body, and the like.
According to one aspect of the present invention there is provided a fastening device to be associated with a first object, for the attachment of said object to a second object, the device comprising at least one fastening element having a base portion and at least one securing portion, said fastening element being originally produced with its securing portion having a first orientation relative to the base portion and with a possibility to bring the securing portion into a second orientation relative to the base portion, to allow said at least one securing portion to penetrate said second object being exposed thereto while staying in said second orientation, and being adapted to change said second orientation into said first orientation to provide said attachment.
The fastening element of the above device may comprise a restrainable portion between the base and securing portions, said fastening element being originally produced with its securing portion having said first orientation relative to the base portion and with the possibility to bring the securing portion into the second orientation relative to the base portion by restraining said restrainable portion so as to enable the securing portion to return from its second orientation to its first orientation when the restraint is released from the restrainable portion; the fastening element in said device having a penetration state in which said restrainable portion is restrained to keep said at least one securing portion in said second orientation constituting its a penetration orientation, to allow said at least one securing portion to penetrate said second object while staying in said penetration orientation, and being adapted to change said penetration state to an attachment state in which said restraint is released to let said at least one securing portion return to its said first orientation, constituting an attachment orientation thereof at which the first object is attached to the second object.
In the context of the present application, the term “restrainable portion” refers to a portion of the fastening element, whose state in this element as originally produced is considered herein to be an ‘unrestrained state’, and which may be deformed or mechanically operated when a so-called ‘restraining force’ is applied thereto directly or indirectly; the restraining portion returns to its original state when the restraining force is released.
According to another aspect of the invention, there is provided a fastening device with plurality of fastening elements as described above and a plurality of restraining elements, which may be in the form of holders mounted thereon, each for keeping the restraining portion of at least one fastening element in the restrained state, each of said restraining elements being adapted for applying thereto of an actuating force for releasing the restrainable portions and thereby letting the securing portions of the fastening elements to return into their attachment orientation.
It should be noted that the orientation of the securing portion of the fastening elements may be established not only with respect to the base portion but also with respect to an object to be penetrated or certain point or surface thereon.
The restraining elements may be movable relative to their fastening elements between a restraining position in which the restraining element applies, directly or indirectly, a restraining force to the restrainable portion to keep said at least one securing portion in said penetration orientation, and a releasing position to remove said restraining force from said restrainable portion, thereby bringing the at least one securing portion to said attachment orientation.
The fastening device may further comprise a carrier with at least one carrying portion to which more than one said fastening element is mounted. The carrier may be adapted for changing its state between a collapsed state in which the fastening elements are disposed relatively remote from said second object to be penetrated, and an expanded state in which at least a part of the fastening elements are brought into vicinity of the second object and are caused to penetrate said object. When the carrier is in its collapsed state, the fastening elements may be oriented in a direction different from the direction of penetration, the carrier being adapted to align the fastening elements with the direction of penetration prior to being brought into vicinity with the second object.
The fastening device may be produced with its carrier in the collapsed state as described above, in which state it may be kept by exerting thereon of a compression force thereon, e.g. by a sheath, with a possibility of essentially simultaneously aligning the fastening elements in the penetration direction, when the compression force is withdrawn. The expansion of the carrier and brining it into the collapsed state may be performed by the inflation and deflation, respectively, by a balloon.
The carrier may constitute a part of actuating means for applying actuating force to the restraining elements, which may be achieved by providing the carrier with an arrangement adapted to apply to each said restraining element said actuating force upon the carrier having expanded to a predetermined extent. Thus, for example, upon the penetration of an object to a predetermined extent, further expansion of the carrier may cause release of said restraining force, changing thereby the orientation of the securing portions of the fastening elements from the penetration orientation to the securing orientation.
Alternatively, each fastening element may be provided with an arrangement adapted to apply to the restraining element said actuating force upon said at least one securing portion having penetrated the second object to a predetermined extent. Thus, for example, upon the penetration of the second object until its contact with said holder, further expansion of the carrier may cause the holder to move relative to fastening element, thereby releasing said restraining force.
According to a further aspect of the present invention, there is provided a method for the attachment of a first object to a second object, comprising:
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- providing at least one fastening element extending in a penetration direction, projecting from or connected to said first object and having a securing portion, the fastening element being adapted to change its state between a penetration state in which the securing portion has a penetration orientation suitable to penetrate said second object, and an attachment state in which said securing portion has an attachment orientation transverse to the penetration orientation, wherein said attachment orientation of said securing portion is a predetermined state with which said fastening element was originally produced with a possibility to bring the securing portion into the penetration orientation by applying to the fastening element a restraining force and to enable the securing portion to return from its second orientation to said predetermined state when the restraining force is withdrawn;
- causing at least the securing portion while in the penetration orientation, to penetrate said second object; and
- withdrawing said restraining force to have the fastening element change its state to said attachment state.
Fastening devices according to the present invention may be advantageously used for the attachment to each other of tubular objects in a side-to-side, end-to-side or end-to-end manner. One example of such use is a side-to-side attachment of a stent graft deployed in a blood vessel to the blood vessel's wall. In such applications, the fastening device may constitute an integral part of a stent which is part of the stent graft, the stent constituting a carrier having at least one carrying portion on which said at least one fastening element is mounted. Alternatively, the fastening device may be formed separately from the stent graft, in which case said device further comprises a carrier with at least one carrying portion on which said at least one fastening element is mounted, the stent graft having at least one connection area, said carrier being insertable into the interior of the stent graft to allow said fastening element to penetrate said graft at, and to project from, said connection area. In this case, the fastening device needs to be deployed within stent graft. According to a still further aspect of the present invention, there are provided means and method for positioning and centering a fastening device relative to a blood vessel, by means of a stent having an upper and a lower portion, each being collapsible and expandable independently of the other, the fastening device being attached to the lower portion of the stent. In the original state of the stent, both portions are collapsed by an exertion thereon of a compression force, e.g. by a sheath. Further, the compression force is withdrawn from the upper portion of the stent, whose circumference is thus brought into contact with the surrounding blood vessel's wall, due to which a proper positioning and, possibly, centering of the lower portion of the stent and the fastening device attached thereto, is achieved relative to the blood vessel.
According to a still further aspect of the invention, there are provided means and method for centering said fastening device relative a stent graft or another tubular object within which it is to be deployed.
According to a still further aspect of the present invention, there is provided a stent adapted for being deployed in a blood vessel and having at least one connection area, the stent being adapted, at least after having been deployed in the blood vessel, to function as a fastening device and to comprise at least one fastening element such as those described above, projecting from said connection area in a penetration direction and having a securing portion capable of changing its orientation relative to said penetration direction between a penetration orientation allowing at least said securing portion to penetrate the blood vessel's wall, and an attachment orientation in which the securing portion is oriented transversely to the penetration direction and is adapted to at least partially press said vessel's wall towards said connection area of the stent.
The stent may have all features described above with respect to the carrier of the fastening device. In particular, the stent may be adapted for changing its state between a collapsed state in which the fastening elements are disposed relatively remote from the blood vessel's wall, and an expanded state in which at least a part of the fastening elements are brought into vicinity of the wall and are caused to penetrate the wall. When the carrier is in its collapsed state, said fastening elements may be oriented in a direction different from the direction of penetration, and wherein prior to bringing the fastening elements into the vicinity of the wall, the carrier is adapted to align the fastening elements with the direction of penetration.
The stent's carrier may have carrying portions to which said fastening elements are mounted, said carrying portions being adapted to change their shape and/or orientation relative to adjacent portions of the carrier, thereby changing special disposition of the fastening elements between their penetration disposition at which the securing portions thereof have said penetration orientation and said attachment orientation in which the securing portion is oriented transversely to the penetration direction. This may be achieved, for example, by said carrying portions being adapted undergo a plastic deformation for changing their shape and/or orientation, e.g. upon the carrier having been brought into said expanded state. Alternatively, the fastening elements may be capable of moving with respect to said carrier to change the orientation of said securing portion.
The stent's carrier may have a plurality of carrying portions and said fastening elements may be mounted to said carrying portion so as to be stationary relative thereto, the carrier constituting, or being connectable to, said first object, said carrying portions of the carrier being plastically deformable to change their initial state in which the fastening elements are directed in a penetration direction to penetrate said second object, to theirs final state in which the fastening elements are directed transversely to said penetration direction to at least partially press said second object towards said carrier.
According to a still further aspect of the invention there is provided a method for producing a fastening device with at least one fastening element as described above, to be associated with a first object, for the attachment of said object to a second object, the device comprising at least one fastening element having a base portion and a securing portion capable of changing its orientation relative to the base portion between a penetration orientation in which the securing portion is adapted to penetrate said second object, and an attachment orientation transverse to the penetration orientation, said method comprising:
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- producing said fastening element with said securing portion in an initial orientation at least similar to the attachment orientation with a possibility of changing said initial orientation to a penetration orientation when the restraining force is applied thereto; and
- placing a restraining element on the fastening element so as to apply thereto said restraining force to bring the securing portion in said penetration orientation, said restraining element being movable in a direction along the fastening element, to remove said restraining force from the securing portion, thereby bringing the securing portion in said attachment orientation, the restraining element having an dimension in said direction shorter than the fastening element.
The fastening element(s) in the fastening device produced as described above may be so designed that their base and securing portions are separate parts mechanically connected to each other at said restrainable portion. Alternatively, some or all the fastening elements may be in the form of a single body elastically deformable at least at said restrainable portion. In this case, the fastening elements may comprises or be made of a super-elastic material or shape-memory material. The latter materials have the property of phase change under certain conditions, the fastening element being thus produced when the material is in its one phase (e.g. under high temperature), then is cooled to be transformed into its second state (e.g. at a lower temperature), to bring the securing portion of the fastening element into its penetration orientation, and later returns to its original state (e.g. by the temperature increase), when it needs to take its attachment orientation.
One specific state in which the fastening element as described above may be originally produced is a bent state achieved by applying to the fastening element bending force. Thus, said securing portion will be in its penetration orientation when the fastening element is in its non-bent state and will be in its attachment orientation when the fastening element is in its bent state. In this case, the fastening device may further comprise means for keeping the fastening element in its non-bent state by providing a compensating force against said bending force by at least one holder, and allowing the bending force to bend the fastening element at said bending area by moving of said at least one holder relative to the at least one fastening element.
According to a further aspect of the present invention, there is provided a fastening device for the attachment of a first object to a second object, the device comprising a carrier having at least one carrying portion and at least one fastening element mounted to said carrying portion so as to be stationary relative thereto, the carrier constituting, or being connectable to, said first object, said at least one carrying portion of the carrier being plastically deformable to change its initial state in which the fastening element is directed in a penetration direction to penetrate said second object, to its final state in which the fastening element is directed transversely to said penetration direction to at least partially press said second object towards said carrier.
In order to understand the invention and to see how it may be carried out in practice, embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings, in which:
One, simplified example of a fastening device according to the present invention is shown schematically in
Generally, the fastening device 11 can constitute a part of a first object to be attached to a second object by the fastening elements penetrating the second object, or it may be used for the attachment of one object to one or more other objects by the penetration of all these objects by the fastening elements. In the former case, in
A more particular example of the use of the fastening device 11 for the attachment of a stent graft aimed to be deployed in and attached to a blood vessel by the penetration of the blood vessel's wall by the fastening elements 15 and securing the attachment thereby. The fastening device can constitute an integral part of the stent, in which case the carrier 13 will be a carrying portion of the stent, i.e. its portion at which the fastening elements 15 are mounted and from which they protrude to penetrate the blood vessel's wall. The fastening device can also be produced separately from the stent and may be adapted for being deployed therein. In this case, the stent graft will have a connection area (not shown), and the fastening elements will penetrate the graft in said area and protrude outwardly therefrom. In the fastening device
In view of the above, and for better understanding only, in further description of the fastening device 11 and other fastening devices having carriers, each carrier should be considered, where appropriate, to constitute either the carrying portion of a stent with which it is integrally formed, or the connection area of a stent graft into which it is deployed.
It should be noted that though in
The above is achieved by producing fastening element 15 from an appropriate material as described below, so that, in an initial state, its securing portion 18 has an orientation similar or identical to its planned attachment orientation, then bringing the securing portion 18 into the penetration orientation and restraining the restrainable portion 19 to keep the securing portion in this orientation during the entire penetration process (as will be described in more detail below), and finally releasing the restrainable portion 19 to bring the securing portion 18 to the attachment orientation. The securing portion 18 in its attachment orientation does not have to be strictly perpendicular to the base portion 19 but rather may form therewith any obtuse or acute angle, and in its penetration orientation it does not have to be fully aligned with the base portion 19, but may rather be slightly inclined relative thereto.
The fastening elements may be made of an elastic or super elastic material, shape memory material or alloy, e.g. such as Nitinol or any other appropriate material allowing the fastening elements 15 to be first elastically deformed, e.g. at their restrainable portion, then kept in the deformed state for a period of time by a restraining means acting on the latter portion, and finally be returned to their initial, deformed state by releasing the restraining means. The simplest example of the above deformation of the fastening element 15 is its bending at the restrainable portion 19.
Referring to
With reference to
The holder 41, 51 is adapted to move when an actuating force F is applied thereto during the penetration process, which is achieved in different ways as shown in the respective figures as explained below.
In the holder 41 in
In the holder 51 in
It should be noted that the holder 41, 51 and 61 does not need to be in the form of a sleeve but may have any other form suitable or not for the holder to enter an object to be penetrated together with the securing portion 18 of the fastening element 15. Moreover, it may be shorter than the length of the restrainable portion or may not cover it at all. For example, as shown in
In addition, the above described holders may be of a design allowing to keep the fastening element 15 with its securing portion 18 at a desired inclination relative to the base portion, as shown in
In all the above examples, the holders are kept in their initial position on the fastening elements 15 by friction, being tightly mounted thereon, and when caused to move along the fastening elements by an actuating force, this force has to be greater than the friction force. However, as will be described below with reference to
In addition, to facilitate the interaction between holders and the fastening elements, their interacting surfaces may have specific mating shapes to provide a rotational component to the movement of the holders along the fastening elements.
Fastening elements, in their penetration state may have initial spatial disposition with respect to a carrier, different from that in which the fastening element is directed in the direction of penetration. In these cases, measures need to be taken to move the fastening elements from their initial disposition to alignment with the direction of penetration. Some examples are shown in
A fastening device according to the present invention may comprise more than one array of fastening elements arranged at different locations along its height.
Various embodiments of a fastening element according to the present invention will be now discussed, in a fastening device with any restraining means described above.
The fastening element can be either a single body having the base, the restrainable and the securing portions as described above or it can have these portions mechanically connected to each other. In both options, the restrainable portion 19 of the fastening element is adapted to be restrained as described above, and the securing portion 18 is adapted to change its orientation relative to the base portion 17 due to the release of the restrainable portion 19.
The fastening element may have more than one of each of the previously mentioned portions, each of which do not necessarily have to be straight as described in previous examples.
The restrainable portion 135 is shown in
Referring to
The fastening element according to the present invention can have more than one couples each comprising one restrainable portion and one securing portion.
The process of using a fastening device according to the present invention will now be explained with respect to its use for the treatment of abdominal aortic aneurysms, the underlying weakness in the wall of the aorta which may rupture if it is too large. In the treatment procedure a stent graft is inserted into the aorta (hereinafter: ‘blood vessel’) and then expanded to be fixed therein. The stent graft is aimed at excluding the flow through the aneurysm with subsequent restoration of normal blood flow (via the graft). This, in turn, prevents the aneurysm from rupturing. Any of the fastening devices described above may thus be used for the fixation of the stent graft to the wall of the aorta, rather than, or in addition to, fixating stents by a radial force exerted thereby, as in the known stent-grafts. This is specifically advantageous in cases where the aneurysm has approached significant limb or artery such as the renal arteries. In such cases there is no healthy aorta wall available in sufficient length (no ‘neck’) for the deployment of a commercially available stent-graft based on radial force fixation.
In general, in order to use a fastening device according to the present invention, for the above purpose the following stages need to be performed:
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- 1. Preparation of the fastening device for the insertion into the blood vessel; since as described above the fastening device may be produced integrally with a stent graft or separately therefrom, in further description any reference to the carrier of the fastening device should be understood respectively as a stent graft to which fastening elements of the fastening device are mounted, or a connecting area of a stent graft penetrated by fastening elements of a fastening device deployed therein;
- 2. Delivery to the site and positioning the fastening device inside the blood vessel together with or subsequently to the insertion of the stent graft;
- 3. Bringing the fastening device to a state ready for penetration of the blood vessel;
- 4. Penetration process;
- 5. Attachment of the stent graft to the blood vessel.
Stage 1 above is usually a part of manufacturing procedure, whereas stages 2 to 5 above are conducted within a patient and together are referred to as a deployment process.
Preparation of the Fastening Device for the Insertion into the Blood Vessel
When inserted into the blood vessel the fastening device should be in a folded or collapsed state, in order to be small enough to be delivered through the relevant parts of the vascular system. In such state the carrier is in its collapsed state and the fastening elements are in their penetration state, but in a disposition different from the desired deposition they should take for the securing orientation of their securing portions to be in the direction of penetration. Examples of such collapsed dispositions were previously described with reference to
The fastening device is delivered to the aneurysm according to common methods known in the art with the use of e.g., guide wires and catheters. Once the folded fastening device has been delivered to the aneurysm, the positioning takes place. In order to position the fastening device in the correct location inside the blood vessel positioning means are used.
With reference to
Once the fastening device is positioned inside the blood vessel, the fastening elements are required to be in their penetration state and need to be directed in the penetration direction, i.e. directed radially to the imaginary axis C of the blood vessel. As already explained above, the fastening device is delivered to its desired position inside the blood vessel in the folded state, wherein the fastening elements are not parallel to the penetration direction. Bringing the fastening elements to the penetration direction is performed by removing the external sheath that was covering the fastening device, directly or indirectly, during its insertion into the blood vessel, as explained above.
During the penetration process the carrier is expanded (as showed e.g. in
Before explaining the final stage of the present process, it should be reminded again that the fastening device is not necessary an integral part of the stent graft to be fastened. When the carrier is not a part of the stent graft, the fastening device comprising both the carrier and the fastening elements, is inserted into the blood vessel after the stent graft has already been appropriately positioned therein.
During the penetration process some locking means may be used in order to lock fastening elements 245 to the stent graft.
Attachment of the Stent Graft to the Blood VesselAs explained in some of the examples described above, where fastening elements include restraining means for holding their restrainable portions restrained, the attachment of the stent graft takes place once the restraining means, are released, allowing the securing portions of the fastening elements to take their attachment orientations, such as shown in
As seen in
In the process described above example was used of a side to side attachment (
Claims
1-66. (canceled)
67. A fastening device to be associated with a first object, for the attachment of said object to a second object, the device comprising at least one fastening element having a base portion and at least one securing portion, said fastening element being originally produced with its securing portion having a first orientation relative to the base portion and with a possibility to bring the securing portion into a second orientation relative to the base portion, to allow said at least one securing portion to penetrate said second object being exposed thereto while staying in said second orientation, and being adapted to change said second orientation into said first orientation to provide said attachment.
68. A fastening device according to claim 67, wherein said at least one fastening element comprises a restrainable portion between the base and the securing portions thereof, said fastening element being originally produced with its securing portion having said first orientation relative to the base portion and with the possibility to bring the securing portion into said second orientation relative to the base portion by restraining said restrainable portion so as to enable the securing portion to return from its second orientation to its first orientation when the restraint is released from the restrainable portion; the fastening element in said device having a penetration state in which said restrainable portion is restrained to keep said at least one securing portion in said second orientation constituting its a penetration orientation, to allow said at least one securing portion to penetrate said second object while staying in said penetration orientation, and being adapted to change said penetration state to an attachment state in which said restraint is released to let said at least one securing portion return to its said first orientation, constituting an attachment orientation thereof at which the first object is attached to the second object.
69. A fastening device according to claim 68, being a medical fastening device adapted for use with a stent.
70. A fastening device according to claim 69, wherein said stent comprises a stent graft and said device further comprises a carrier with at least one carrying portion on which said at least one fastening element is mounted, the stent graft having at least one connection area, said carrier being insertable into the interior of the stent to allow said fastening element to penetrate said stent graft at, and to project from, said connection area.
71. A fastening device according to claim 69, constituting an integral part of said stent, the stent constituting a carrier having at least one carrying portion on which said at least one fastening element is mounted.
72. A fastening device according to claim 67, further comprising a carrier with at least one carrying portion to which more than one said fastening element is mounted.
73. A fastening device according to claim 70, wherein the device comprises a plurality of fastening elements and a plurality of restraining elements each for keeping the restraining portion of at least one fastening element in the restrained state, each of said restraining elements being adapted for applying thereto of an actuating force for releasing the restrainable portions and thereby bringing the securing portions of the fastening elements into their attachment orientation.
74. A fastening device according to claim 73, wherein said carrier is provided with an arrangement adapted to apply to each said restraining element said actuating force upon the carrier having expanded to a predetermined extent defined by the length of said at least one securing portion.
75. A fastening device according to claim 73, wherein at least one of said restraining elements is movable relative to said fastening element between a restraining position in which the restraining element applies, directly or indirectly, a restraining force to the restrainable portion to keep said at least one securing portion in said penetration orientation, and a releasing position to remove said restraining force from said restrainable portion, thereby bringing the at least one securing portion to said attachment orientation.
76. A fastening element according to claim 73, wherein said restraining element has a flange disposed at its proximal end and laterally projecting from the restraining element, and is adapted to move upon the application to its flange of a force directed away from said securing portion, said force constituting said actuating force.
77. A fastening element according to claim 76, wherein said flange is disposed at the restraining element's proximal end and laterally projects from the restraining element.
78. A fastening device according to claim 68, wherein said fastening element is a single body elastically deformable at least at said restrainable portion.
79. A fastening device to be associated with a first object, for the attachment of said object to a second object, the device comprising at least one fastening element having a base portion, at least one securing portion and a restrainable portion between the base portion and the at least one securing portion, the fastening element having a penetration state in which said restrainable portion is restrained to keep said at least one securing portion in a penetration orientation relative to the base portion such as to allow said at least one securing portion when in said penetration orientation to penetrate said second object while staying in said penetration orientation, and being adapted to change said penetration state to an attachment state in which said restrainable portion is released to bring said at least one securing portion into an attachment orientation different from the penetration orientation, wherein the attachment state of the fastening element is at least similar to an initial state of the fastening element, which it had before the restrainable portion was restrained, and wherein the device further comprises at least one restraining element mounted on at least said restrainable portion for keeping the restraining portion in the restrained state, the restraining element being adapted for applying thereto of an actuating force for releasing the restrainable portion and thereby bringing the securing portion of the fastening elements into their attachment orientation.
80. A fastening device according to claim 79, wherein the restraining element is movable relative to said fastening element between a restraining position in which the restraining element applies, directly or indirectly, a restraining force to the restrainable portion to keep said at least one securing portion in said penetration orientation, and a releasing position to remove said restraining force from said restrainable portion, thereby bringing the at least one securing portion to said attachment orientation.
81. A fastening device for the attachment of a first object to a second object, the device comprising a carrier having at least one carrying portion and at least one fastening element mounted to said carrying portion so as to be stationary relative thereto, the carrier constituting, or being connectable to, said first object, said at least one carrying portion of the carrier being plastically deformable to change its initial state in which the fastening element is directed in a penetration direction to penetrate said second object, to its final state in which the fastening element is directed transversely to said penetration direction to at least partially press said second object towards said carrier.
82. A stent adapted for being deployed in a blood vessel and having at least one connection area, the stent being adapted, at least after having been deployed in the blood vessel, to function as a fastening device and to comprise at least one fastening element projecting from said connection area in a penetration direction and having a securing portion capable of changing its orientation relative to said penetration direction between a penetration orientation allowing at least said securing portion to penetrate the blood vessel's wall, and an attachment orientation in which the securing portion is oriented transversely to the penetration direction and is adapted to at least partially press said vessel's wall towards said connection area of the stent.
83. A stent according to claim 82, further comprising a graft, constituting together a stent graft, said stent-graft being adapted to receive therein a fastening device comprising a carrier and a plurality of the fastening elements adapted to penetrate said stent graft at a connection area thereof before the penetration of said blood vessel's wall.
84. A stent according to claim 70, wherein said carrier has carrying portions to which said fastening elements are mounted, said carrying portions being adapted to change their shape and/or orientation relative to adjacent portions of the carrier, thereby changing special disposition of the fastening elements between their penetration disposition at which the securing portions thereof have said penetration orientation and said attachment orientation in which the securing portion is oriented transversely to the penetration direction.
85. A method for producing a fastening device to be associated with a first object, for the attachment of said object to a second object, the device comprising at least one fastening element having a base portion and a securing portion capable of changing its orientation relative to the base portion between a penetration orientation in which the securing portion is adapted to penetrate said second object, and an attachment orientation transverse to the penetration orientation, said method comprising:
- producing said fastening element with said securing portion in an initial orientation at least similar to the attachment orientation with a possibility of changing said initial orientation to a penetration orientation when a restraining force is applied thereto; and
- placing a restraining element on the fastening element so as to apply thereto said restraining force to bring the securing portion in said penetration orientation, said restraining element being movable in a direction along the fastening element, to remove said restraining force from the securing portion, thereby bringing the securing portion in said attachment orientation, the restraining element having an dimension in said direction shorter than the fastening element.
86. A method for the attachment of a first object to a second object, comprising:
- providing at least one fastening element extending in a penetration direction, projecting from or connected to said first object, and having a securing portion, the fastening element being adapted to change its state between a penetration state in which the securing portion has a penetration orientation suitable to penetrate said second object, and an attachment state in which said securing portion has an attachment orientation transverse to the penetration orientation, wherein said attachment orientation of said securing portion is a predetermined state with which said fastening element was originally produced with a possibility to bring the securing portion into the penetration orientation by applying to the fastening element a restraining force and to enable the securing portion to return from its second orientation to said predetermined state when the restraining force is withdrawn;
- causing at least the securing portion while in the penetration orientation, to penetrate said second object; and
- withdrawing said restraining force to have the fastening element change its state to said attachment state.
87. A method according to claim 86, comprising providing a plurality of the fastening elements, whose securing portions, when in said attachment orientation, are aligned to form a seam on or in said second object.
88. A method according to claim 87, wherein said fastening element is bendable, the method further comprising changing the state of said fastening element from a non-bent state in which said securing portion is in said penetration orientation, into a bent state in which said element is bent at said bending area and said securing portion is in said attachment orientation.
89. A method according to claim 88, further comprising setting a predetermined bent state to said fastening element by a bending force, before bringing it to said non-bent state.
90. A method according to claim 88, further comprising keeping said at least on fastening element in said non-bent state by providing a compensating force against said bending force by at least one holder, and allowing the bending force to bend the fastening element at said bending area by moving of said at least one holder relative to the at least one fastening element.
91. A method according to claim 86, further comprising keeping said at least one fastening element in said attachment orientation by a locking means.
92. A method according to claim 90, further comprising providing a plurality of the fastening elements mounted on a common carrier.
93. A method according to claim 92, wherein said first and second objects are tubular objects of which the first object is deployed with the second object.
94. A method according to claim 93, wherein said carrier is a part of the first object.
95. A method according to claim 93, wherein said fastening device is deployed within the first object, and said projecting of the fastening elements is achieved by the fastening elements penetrating said first object prior to their penetration of the second object.
96. A method according to claim 94, wherein the carrier is originally in a collapsed state with said fastening elements in their penetration state being directed in a direction different from the penetration direction, the method further comprising essentially simultaneously aligning the fastening elements in the penetration direction.
97. A method according to claim 96, wherein the carrier is capable of collapsing and expanding, and the aligning of the fastening elements in the penetration direction is performed before the carrier is in its expanded state, the expansion causing the fastening elements to penetrate the second object.
98. A method according to claim 97, wherein the collapsed state of the carrier is obtained by exerting a compression force on said carrier by a sheath.
99. A method according to claim 98, wherein the expansion and the collapsing of the carrier is performed by its respective inflation and deflation by a balloon.
100. A method according to claim 99, wherein upon the penetration of the second object to a predetermined extent, further expansion of the carrier causes release of said restraining force, changing thereby the orientation of the securing portions of the fastening elements from the penetration orientation to the securing orientation.
101. A method according to claim 94, wherein upon the penetration of the second object until its contact with said holder, further expansion of the carrier causes the holder to move relative to fastening element, thereby releasing said restraining force.
102. A method according to claim 93, further comprising positioning means for the deployment of the fastening device into a desired position within the second object.
103. A method according to claim 93, further comprising centering said fastening device relative to the axis of said second object.
Type: Application
Filed: Mar 5, 2007
Publication Date: Feb 19, 2009
Applicant: VAYRO LTD. (Kfar-Haim)
Inventors: Yehuda Miron (Kfar-Haim), Yuri Sudin (Modiin), Ron Karmeli (Haifa)
Application Number: 12/224,601
International Classification: A61F 2/44 (20060101); A61B 17/08 (20060101);